NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

I just emailed this to NWBO:

My name is etc.

I would like to make you aware of the following (in case you were not aware of this). By FDA regulation NWBO is required to update ClinicalTrials.gov within 12 months of study completion with the study results.

“The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires results of trials of FDA-regulated products to be reported to ClinicalTrials.gov within 12 months of study completion.”

Just in case there is any misunderstanding about what is meant with “study completion”

“The Primary and Study Completion Dates may be the same date, but they have different definitions. The Primary Completion Date is based on the data collection for the Primary Outcome Measure. The Study Completion Date is based on the last data collection point for the last patient.”

Since the study completion date, data collection of the last patient, was initiated on July 24 2020 as PRed by NWBO on July 24 2020
https://www.prnewswire.com/news-releases/northwest-biotherapeutics-announces-completion-of-phase-3-trial-sites-databases-301099438.html
then this means that the result of the trial on ClinicalTrials.gov must be updated on or before July 24, 2021.

Of course we, shareholders, hope and pray that NWBO will PR topline data long before that date. If not then there will be those that will make the FDA aware of you failing Amendments Act of 2007 (FDAAA) which is what nobody wants.

Thank you for your attention.
Best regards